Abstract
This chapter reviews issues dealing with the handling of biological threat samples within the laboratory. This subject becomes paramount when forensic issues; such as the collection, handling, transporting, stabilizing, extracting, analyzing, securing, archiving, and disposing off of samples is concerned, and the presentation of manipulated data in a court of law is also questioned… Issues that influence a laboratory's implementation of an operational strategy for sample handling that will withstand political, scientific, and legal scrutiny in a court of law are also focused upon. Many of these issues were identified as a result of the U.S. Army Medical Research Institute of Infectious Diseases' (USAMRIID) experience with numerous biological threat samples, the Federal Bureau of Investigation (FBI), prosecuting and defense attorneys, and with quality systems. For the examination of samples, development and implementation of a test plan encompass three principles: (1) State what actions will be performed, (2) perform the stated actions, and (3) document the actions as performed along with any deviations from the test plan. In laboratories where analyses of certain sample types have become routine, test plans may merely follow a series of well-established or validated Standard Operating Procedures (SOPs). However, attempts to implement an operational strategy with such stringent SOPs can be a daunting task for the vast myriad of biological threat agents, types of matrices, assay inhibitors, stabilization requirements, variations in concentration, etc. Therefore, flexibility is required in the initial phases of a test plan to allow modification of the operational strategy and SOPs to accommodate variations.
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